AIDS Activism Improves Medicine

Last week, in the waning hours of the 102nd session, Congress passed
legislation that permitted the Food and Drug Administration to charge drug
companies for reviewing new drug applications.

The legislation looked, on the surface, like a simple bargain between the
drug industry and the FDA: If pharmaceutical companies agreed to pay the
agency millions of dollars for a variety of regulatory services, the FDA
would devote all the new money to expanding and computerizing its drug
review operation.

But the real impetus for the reform -- one of the most significant in the
agency's history -- came from an unexpected place: the AIDS activists who
have been pressuring the FDA for close to a decade. According to FDA
officials, it was the FDA's experience in reviewing AIDS drugs quickly, and
in devoting extra attention to that disease, that led them to believe they
could speed up the review of all drugs if given the necessary resources.

Among policymakers, physicians and legal experts, this has become a
familiar story. Ten years of AIDS activism, they say, has had a profound
impact on U.S. regulation, law and society far beyond the immediate world
of those infected with the HIV virus. The outpouring of grief, expressed so
eloquently in the AIDS quilt that was displayed on the Mall last weekend,
also has changed the way medical science is conducted, the relationship
between doctor and patient, the way Americans talk about sex, the way drugs
are regulated and the way civil rights law is written.

"You can look at all of the major cutting edge issues in health law and
ethics and you can see how AIDS has had an impact," said Lawrence Gostin,
executive director of the American Society of Law and Medicine in Boston.
"It is the lens we use to examine all the critical issues."

In the case of user fees, for example, the FDA pledged to cut by almost
half the amount of time it takes to review new drugs and to review
so-called breakthough drugs in no longer than six months if the
pharmaceutical industry paid the FDA $300 million in fees over five years.
Agency officials said they were able to make this pledge because of their
experience with the AIDS drugs DDI and DDC. Both were approved in record
time because of pressure by AIDS activists, showing that extra resources
could be translated into faster scientific reviews.

A series of regulatory changes enacted at the FDA this year, in fact, which
allow experimental drugs for lifesaving diseases to be made available to
patients before they are approved, are all legacies of the demands of AIDS
activists to loosen up the drug approval process, which averages 20 months.

"Back in the 1960s and 1970s, post-thalidomide, the agency's mission was to
keep unsafe products off the market," FDA Commissioner David A. Kessler
said. "But in dealing with AIDS, we have learned in no uncertain terms that
our job is not only to keep unsafe drugs off the markets but to get safe
and effective drugs to the market. This will carry over to traditional
drugs as well. ... The pendulum has swung."

AIDS has had a more subtle, but no less significant, effect in reshaping
the face of health and civil rights law. Since the epidemic began, there
have been 469 court cases and administrative agency legal actions related
to AIDS, on subjects as diverse as education, crimimal law, family law,
confidentiality and discrimination.

Consider, for example, how AIDS has changed just one of those areas: the
1990 Americans with Disabilities Act. The law covers areas traditionally
associated with disabilities: how facilities must be accessible to those in
wheelchairs, how the blind or the deaf cannot be discriminated against in
employment or housing. But in one significant respect it differs from
previous civil rights legislation. At the insistence of AIDS activists, the
law covers HIV infection as a disability.

"If it had followed it's predecessors, the ADA would not have mentioned or
barely been applicable to health," said Gostin. "It used to be that if you
had cancer or Huntington's disease and someone said, `I'm not going to
employ you any more, I'm not going to let you go on a senior management
program,' you couldn't do anything. It wasn't because you were a woman. It
wasn't because you were black. But what this means is that whenever you are
denied a service, excluded from a job or a school, or whenever you have any
compulsory power exercised against you because of an illness, you have a
remedy. You can go to a federal court and sue for discrimination."

What AIDS activists have done, say medical experts, is to assert the
interests and demand of those actually suffering from a disease far more
effectively than any previous group of patient advocates. In so doing, they
have provided a model for other groups to follow.

"People with AIDS were the first to say that we're not victims and to
demand a full partnership with their physicians," said Deborah Cotton, an
AIDS physician and researcher at Beth Israel Hospital in Boston. "To me
that is the biggest change, and it is spilling over to other patients.
Paternalism in medicine was on the way out, but with AIDS it's dead."